Field of the Disclosure
The present disclosure is related to the medical field and, more particularly, to a fluid container, such as an intravenous (IV) bag, and a method of analyzing, identifying, and verifying, fluid contained in the container.
Description of Related Art
IV bags are used for intravenous infusion of fluids, such as medicinal or therapeutic agents, volume expanders, blood-based products, blood substitutes, nutrient solutions, and buffer solutions during treatment of a patient. Typically, the IV bag is connected to a catheter or a needle through flexible medical tubing. The catheter or needle is inserted into a patient's vein at a vascular access site.
An IV bag is often formed from a flexible clear or translucent material, such as medical-grade polyvinyl chloride (PVC). Other suitable polymer materials may also be used for certain applications. The interior of the IV bag is accessible through a port or opening extending through a portion of the bag. The port may be covered by a piercable plug, stopper, or septa, which is often formed from an elastomeric material. The port may include a connector structure for attaching medical tubing to the port. Alternatively, the port may be an appropriate size to permit medical tubing to fit over a portion of the port to form a secure friction engagement or connection therewith.
When performing a medical procedure, it is normal for the technician, nurse, physician, or other medical professional, which are collectively referred to hereinafter as users, to verify that the contents of the IV bag are correct for the procedure being performed. Most simply, a label may be affixed to the bag that lists information about the fluid contained therein. For example, the label may include printed text with the name and concentration of the drug contained in the bag. The label may also include icons or pictures conveying additional information, such as warnings that the drug is contraindicated for certain patients. The label may also include various indicia that can be read by a scanner or imaging device, such as bar codes, QV codes, near field communications or radio frequency chips, and the like. The user is typically responsible for checking the label and, if necessary, scanning any readable indicia prior to performing any procedure.
A user may also test the solution of the IV bag directly to verify that the solution is correct for the procedure being performed. Optionally, this test may be performed by inserting a syringe into the interior of the bag through the port and drawing a small amount of fluid from the bag into the syringe. The extracted solution is expelled from the syringe to a test device, such as a test strip or lateral flow assay. The test strip or assay includes a reagent that reacts with the solution, indicating the type of solution provided. The fluid may also be provided to various electronic testing devices, meters, or sensors to identify the fluid solution.
In some medical applications, a solution is prepared immediately prior to delivery to a patient. In that case, the user obtains an IV bag filled with a first solution. The user inserts the syringe, as described above, and draws a predetermined amount of the first solution from the bag to create vacant space in the bag. The user then removes the syringe and inserts a new syringe, containing a second solution, such as a therapeutic agent, and injects the second solution into the bag to fill at least a portion of the vacant space. The bag can then be mixed by shaking or inverting the bag to ensure that the solutions are properly mixed together. The user may then test the mixed solution to verify that the desired concentration of solutions has been obtained.
However, testing fluid contents of an IV bag by drawing fluid from the bag and expelling the fluid to a testing device may be time consuming and inefficient. In addition, some therapeutic agents, such as chemotherapy agents, become toxic when mixed. Accordingly, it is often desirable to prevent the user from contacting the solution before or after mixing. Therefore, there is a need for a testing device or apparatus that is integrated with the bag or fluid infusion system to improve efficiency of the fluid testing and verification process. The testing apparatus should assist in identification of the fluid contents of the IV bag. The testing mechanism should also reduce or eliminate contamination opportunities, where the user comes into contact with any sort of toxic substance.
A number of electronic sensors and testing systems that are associated with an IV bag or infusion set are known. U.S. Pat. No. 5,563,584 to Rader et al. discloses a liquid level sensing system for a fluid infusion system. The sensing system includes a pressure sensor, such as a flexible diaphragm arrangement, connected to a port of an infusion bag. Various resistive or capacitive sensors may be used in place of a pressure sensor. Fluid flow through the port may be controlled by a valve. The pressure sensor is used to determine the volume of fluid in the IV bag and, if fluid volume is determined to be below a predetermined amount, to signal an alarm so that the IV bag can be refilled or replaced.
U.S. Pat. No. 8,066,127 to Coelho et al. discloses an apparatus and method for automatically separating whole blood contained in a fluid bag into separate components. Fluid flow from the bag is controlled by a valve. The valve is selectively opened and closed based on readings from a sensor that differentiate between the different blood components. The sensor may read various characteristics of the blood to differentiate between blood components, such as infrared emission, density, weight, radioactive emission, fluorescence, color, magnetism, or capacitance. The valve opens to allow fluid having a similar measured characteristic to be collected in a container. When a change in the measured characteristic is detected, the valve automatically closes to allow collection of the fluid in another container.
U.S. Pat. No. 8,425,487 to Beiriger et al. discloses a fluid delivery system including a vial spike for accessing the fluid contents of a medical vial. A sensor may be associated with the spike or with a fluid line extending from the vial. The sensor is used to confirm that the vial is correctly attached to the vial spike and that fluid is capable of flowing from the vial through the spike. The sensor may be an optical sensor, load sensor that detects the mass of the vial, or a conductivity sensor. The fluid delivery system may also include a frame having multiple needle spikes so that a number of vials can be simultaneously connected to the fluid delivery system.
Although the above-described systems provide some information about fluid volume in a container or about whether a good connection with the container is established, the known systems generally do not identify the type of fluid contained in the container.